Armed with Indian approval, Gilead forges ahead with Sovaldi and its licensed copies

SINGAPORE--Undeterred by its loss of a new patent bid for its Sovaldi (sofosbuvir) hepatitis C drug in India, Gilead Sciences ($GILD) put together package deals with 8 of the country's generics makers to add an experimental drug to a deal for low-cost copies in 91 poor countries around the world. Meanwhile, Gilead said Sovaldi won marketing approval this month in India and it's off and running in that country.

Gilead is working on a follow-up to Sovaldi, which it now markets widely around the globe at prices apparently based on the wealth of the country. It began in the United States at $84,000 for a 12-week course and despite the price, has proven as popular as it is effective. In India and Egypt, the price is about $900 for the same therapy, about the lowest it has charged.

The company has come under strong criticism for charging high prices on Sovaldi and a combination pill, Harvoni. In response, Gilead reached an agreement last September with 8 India-based generics companies to offer generic versions of the drug at a lower price in India and 90 other nations, which together would cover 54% of the world's HCV patients. The agreements also covered Harvoni, which combines sofosbuvir with ledipasvir.

This week, it came back with a new offer to the same 8 companies: Biocon, Cadila Healthcare, Cipla, Hetero Labs, Mylan Laboratories ($MYL), Ranbaxy Laboratories, Sequent Scientific and Strides Arcolab. It seems Gilead had just announced it received Indian marketing approval for sofosbuvir. And it said it would add that experimental drug, GS-5816, to the licensing deal.

Gilead said, "Sofosbuvir recently received regulatory approval in India (January 2015), and regulatory submissions have been completed in additional countries, including Pakistan, Thailand, Brazil, Uganda, South Africa and Nigeria." The 8 generics makers, free to set their own prices, would still be competing against Gilead and the brand. The company recently negotiated lower prices with Germany's regulators.

What about that rejection from the Indian Patent Office? That, explains Gilead, was for a compound covering the drug's metabolites. As it appeals that decision, it said GS-5816 can treat all 6 genotypes of hepatitis C in combination with Sovaldi.

The GS-5816 cocktail is in Phase III trials that Gilead expects to be complete successfully in the second half of this year. In India, however, Gilead said it plans to ask regulators to waive trial requirements to speed its approval and give patients quick access. That is something India has done in the past.

Not everyone in the medical profession is happy with Gilead's machinations. Médecins sans Frontières, the volunteer doctor group, said Gilead's licensing agreements do nothing to ensure "widespread access" to its new drugs, partly because the latest ones for GS-5816 would still limit where the drug could be sold.

- read the press release

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